NCT00889772

Brief Summary

The purpose of the study is to externally validate the acute lung injury/acute respiratory distress syndrome (ALI/ARDS) prediction model (Lung Injury Prediction Score - LIPS) in a multicenter sample of patients at risk presented to the acute care hospitals: United States Critical Illness and Injury Trials Group (USCIITG).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

September 24, 2015

Status Verified

June 1, 2012

Enrollment Period

11 months

First QC Date

April 27, 2009

Last Update Submit

September 22, 2015

Conditions

Keywords

Respiratory distress, adultriskemergency roomhigh risk surgerysepsistraumaaspirationpneumonia

Outcome Measures

Primary Outcomes (1)

  • Acute Lung Injury or Acute Respiratory Distress Syndrome

    during hospital stay

Secondary Outcomes (1)

  • Survival

    in hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients \>18 years of age with one or more predisposing conditions for ALI/ARDS (pneumonia, sepsis, shock, pancreatitis, aspiration, high risk trauma and high risk surgery) at the time of hospital admission

You may qualify if:

  • Hospitalized adult patients with one of the known risk factors for acute lung injury at the time of hospital admission

You may not qualify if:

  • ALI/ARDS already present at the time of hospital admission, denied use of medical records for research, children, hospital readmission, transfer from another hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (4)

  • George N, Elie-Turenne MC, Seethala RR, Baslanti TO, Bozorgmehri S, Mark K, Meurer D, Bihorac A, Aisiku IP, Hou PC; U.S. Critical Illness and Injury Trials Group-Lung Injury Prevention Study Investigators. External Validation of the qSOFA Score in Emergency Department Patients With Pneumonia. J Emerg Med. 2019 Dec;57(6):755-764. doi: 10.1016/j.jemermed.2019.08.043. Epub 2019 Nov 15.

  • Chang SY, Dabbagh O, Gajic O, Patrawalla A, Elie MC, Talmor DS, Malhotra A, Adesanya A, Anderson HL 3rd, Blum JM, Park PK, Gong MN; United States Critical Illness and Injury Trials Group: Lung Injury Prevention Study Investigators (USCIITG-LIPS). Contemporary ventilator management in patients with and at risk of ALI/ARDS. Respir Care. 2013 Apr;58(4):578-88. doi: 10.4187/respcare.01755.

  • Gajic O, Dabbagh O, Park PK, Adesanya A, Chang SY, Hou P, Anderson H 3rd, Hoth JJ, Mikkelsen ME, Gentile NT, Gong MN, Talmor D, Bajwa E, Watkins TR, Festic E, Yilmaz M, Iscimen R, Kaufman DA, Esper AM, Sadikot R, Douglas I, Sevransky J, Malinchoc M; U.S. Critical Illness and Injury Trials Group: Lung Injury Prevention Study Investigators (USCIITG-LIPS). Early identification of patients at risk of acute lung injury: evaluation of lung injury prediction score in a multicenter cohort study. Am J Respir Crit Care Med. 2011 Feb 15;183(4):462-70. doi: 10.1164/rccm.201004-0549OC. Epub 2010 Aug 27.

  • Trillo-Alvarez C, Cartin-Ceba R, Kor DJ, Kojicic M, Kashyap R, Thakur S, Thakur L, Herasevich V, Malinchoc M, Gajic O. Acute lung injury prediction score: derivation and validation in a population-based sample. Eur Respir J. 2011 Mar;37(3):604-9. doi: 10.1183/09031936.00036810. Epub 2010 Jun 18.

MeSH Terms

Conditions

DyspneaAcute Lung InjuryEmergenciesSepsisWounds and InjuriesPneumonia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLung InjuryLung DiseasesDisease AttributesPathologic ProcessesInfectionsSystemic Inflammatory Response SyndromeInflammationRespiratory Tract Infections

Study Officials

  • Ognjen Gajic, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant - Critical Care

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 29, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

September 24, 2015

Record last verified: 2012-06

Locations